08.17.2026

Duravyu Misses Primary Endpoint in Phase 3 LUGANO Trial but Reduces Treatment Burden in Wet AMD

Key Takeaways Duravyu 2.7 mg missed the primary noninferiority endpoint versus on-label aflibercept 2 mg in the full LUGANO dataset, but an ad hoc analysis excluding 9 of 211 patients (4%) showed noninferiority (nominal P = .0096) Duravyu 2.7 mg reduced treatment burden by 42% versus aflibercept 2 mg (nominal P < .0001); 76% of patients were supplement-free through week 32 and 54% remained supplement-free through week 56 Among Duravyu-treated patients, 94% received zero or one supplemental injection through week 32 and 79% received zero or one supplemental injection through week 56 EyePoint announced that Duravyu (vorolanib intravitreal insert) 2.7 mg did not meet the primary endpoint of noninferiority to on-label aflibercept 2 mg in the full dataset of the phase 3 LUGANO trial in wet age-related macular degeneration (AMD), although an ad hoc analysis excluding 9 of 211 Duravyu-treated patients showed noninferiority (nominal P = .0096). The excluded patients, representing 4% of the Duravyu group, experienced vision loss of 15 or more letters that EyePoint said was unrelated to wet AMD.